Same-day Lenacapavir PrEP with follow-up choice to see if people stay on PrEP longer
Official title: PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
Run by Massachusetts General Hospital · NCT07335289 · Data updated 2026-11-12
This trial tests whether letting people choose where they get follow-up care after starting lenacapavir PrEP helps them stay on PrEP longer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | July 17, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07335289 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
HIV-negative individuals who are eligible for CDC PrEP guidelines, willing to receive injectable lenacapavir, and residing in Massachusetts with plans for 6-month follow-up.
✕Probably not a fit
Individuals not willing or able to receive injectable lenacapavir or not residing in Massachusetts are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PrEP4U is a pragmatic randomized study evaluating real-world implementation of injectable lenacapavir for HIV PrEP. Participants start lenacapavir the same day after rapid HIV testing and then choose their follow-up location (home, community, or clinic). The primary goal is to see if follow-up location choice improves PrEP persistence compared with a clinic-only approach. Secondary analyses look at safety of rapid testing, acceptability, and participant costs; exploratory analyses assess HIV incidence and resistance. The trial aims to generate evidence to support scalable, equitable delivery of long-acting PrEP and inform policy and practice in the U.S. and globally.
Why it matters
Potential benefit: If successful, the study could lead to more people staying on PrEP by allowing flexible follow-up options that fit their lives.
How similar studies have gone: Previous PrEP delivery studies show that user-centered, flexible care models can improve uptake and persistence, though this specific lenacapavir and same-day-initiation approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV negative * Eligible for HIV PrEP per CDC guidelines * Able and willing to provide informed consent * Willing to receive injectable lenacapavir and adhere to study procedures * Residing inMassachusetts with expected availability for 6-month follow-up Exclusion Criteria: * Known HIV infection at baseline * Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions) * Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose) * Participation in another interventional HIV prevention study * Any condition judged by the investigator to compromise safety or study integrity
Where it's running
-
Massachusetts General Hospital Sexual Health Clinic
Boston, Massachusetts, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Ruanne V Barnabas, MBChB, PhD — Massachusetts General Hospital
- Study coordinator: Meighan Krows
- Email: mkrows@mgb.org
- Phone: 617-726-2000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Boosting long-acting injectable PrEP use among Latine gay/bisexual men and transgender women in the South
This project will try giving long-acting injectable PrEP (lenacapavir) through a community clinic to Latine gay and bisexual men and transgender women in Durham to see if people stay on PrEP longer.
-
Metabolomic biomarkers for myotonic dystrophy
This study tests whether urine and blood tests, along with muscle function tests, can detect and measure myotonic dystrophy activity and severity without relying on muscle biopsies.
-
Two group-based, telehealth caregiver programs to reduce stress in dementia caregivers
This trial tests whether Caring Together or Savvy Caregiver, delivered by telehealth, best reduces caregiver stress for people caring for someone with memory loss.
-
Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
This study tests a wearable heart rate variability biofeedback tool to see if it helps reduce anxiety in autistic teens.
-
Brillouin hydration mapping to study cornea health
Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.
-
Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa
This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.